Study of Daily Cannabidiol CBD, Tetrahydrocannabinol THC, and Their Combination for Knee Osteoarthritis Pain Relief and Related Symptoms

What this Trial Is About

Researchers are studying how daily use of Tetrahydrocannabinol THC, Cannabidiol CBD, or a combination of both affects knee osteoarthritis pain and related symptoms. The study aims to understand the separate and combined effects of these cannabinoids on inflammation and brain connectivity linked to pain. It is a Phase 2 clinical trial focusing on both central nervous system and peripheral pain mechanisms in knee osteoarthritis. Participants will be randomly assigned to take either THC, CBD, a combination of both, or a placebo. Dosages include up to 150 mgday of CBD, up to 10 mgday of THC, or both combined at these doses. The treatment period lasts about 16 weeks, preceded by a screening phase of up to 30 days, and followed by approximately 2 weeks of follow-up. Dose adjustments may be made if needed, and participants are instructed about meal timing relative to taking the study drug. During the study, participants will undergo clinical pain assessments, blood draws to measure inflammation markers, questionnaires, daily pain diaries, sensory testing, and functional connectivity MRI scans at specific time points. Safety and eligibility will be reassessed two weeks into treatment. The researchers will measure brain connectivity changes and levels of the inflammatory marker IL-6 to evaluate treatment effects. Participants will also be monitored for medication adherence and ability to complete study procedures.

Cannabinoid Interactions With Central and Peripheral Pain Mechanisms in Osteoarthritis of the Knee